Phase 3 Safety and Efficacy Studies Will Be Highlighted
TAMPA, Fla., May 7 /PRNewswire-USNewswire/ -- Acute pain is a significant medical issue in the United States. More than 25 million Americans are said to experience acute pain each year as a result of injuries or surgeries, and a recent study estimated that 42 percent of U.S. hospital emergency department visits were due to pain-related problems.
Seven clinical presentations on tapentadol immediate release (IR) tablets for acute pain, including pivotal Phase 3 safety and efficacy and gastrointestinal tolerability data, will be discussed during the poster sessions of the 27th Annual Scientific Meeting of the American Pain Society (APS) in Tampa, Florida on Thursday, May 8 and Friday, May 9.
These data presentations are supported by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD).
Tapentadol is a novel investigational, centrally acting oral analgesic. It has a unique profile with two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition in a single molecule. It is being developed in immediate-release formulation for acute pain and extended-release formulation for chronic pain.
Mu-opioid agonists are drugs that bind to and activate mu-opioid receptors in the central nervous system. These drugs modify sensory and affective (mood) aspects of pain, inhibit the transmission of pain at the spinal cord and affect activity at parts of the brain that control how pain is perceived. Norepinephrine reuptake inhibitors are a type of central nervous system medication that increases the level of norepinephrine in the brain by inhibiting its re-absorption into nerve cells; these compounds have analgesic properties.
The following tapentadol immediate release studies will be presented at APS:
Thursday, May 8: 4:45 p.m. to 6:15 p.m.
Poster 223: Evidence for a Combined Mode of Action Underlying the Broad Efficacy Profile of Tapentadol, a Novel Centrally Acting Analgesic; Primary investigator: Gregor Bahrenberg, M.D.
Poster 227: Efficacy Profile of Tapentadol, a Novel Centrally Acting Analgesic With a Combined Mode of Action, in Animal Pain Models; Primary investigator: Thomas M. Tzschentke, M.D.
Poster 229: Efficacy of Tapentadol Immediate Release in Patients With Pain After Bunionectomy; Primary investigator: Charles Oh, M.D.
Friday, May 9: 4:00 p.m. to 5:30 p.m.
Poster 214: Symptoms of Opioid Withdrawal After Discontinuation of Tapentadol Immediate Release, an Analgesic with Mu-opioid Receptor Agonism; Primary investigator: David Upmalis, M.D.
Poster 222: Analgesic Efficacy of Tapentadol Immediate Release in Patients With Pain From End-Stage Joint Disease; Primary investigator: Craig T. Hartrick, M.D.
Poster 224: Tapentadol Immediate Release Compared With Oxycodone Immediate Release for the Relief of Moderate-to-Severe Pain in Patients With End Stage Joint Disease; Primary investigator: Marc Afilalo, M.D.
Poster 226: Tapentadol Immediate Release is Associated With Improved Gastrointestinal Tolerability Compared With Oxycodone Immediate Release Over 90 Days in Patients With Lower Back or Osteoarthritis Pain; Primary investigator: Charles Oh, M.D.
Press releases about the clinical studies presented in posters 222, 226, and 229 will be released immediately before presentation of study posters.
The use of tapentadol IR for the treatment of moderate to severe acute pain is under review by the United States Food and Drug Administration. The New Drug Application (NDA) was filed on January 23, 2008. Upon FDA approval, PriCara(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market tapentadol in the United States. The NDA filing is part of the ongoing commitment of J&JPRD and PriCara(TM) to bring new and innovative products to patients and physicians for the treatment and management of pain.
J&JPRD and Ortho-McNeil-Janssen Pharmaceuticals, Inc. are wholly owned subsidiaries of Johnson & Johnson.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD) is a wholly owned subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas, including CNS, Internal Medicine and Oncology, to address unmet medical needs worldwide. More information can be found at http://www.jnjpharmarnd.com/.
PriCara(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
PriCara(TM), a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is a major health care company in the United States dedicated to the needs of primary care providers who serve a vital role on the frontline of medicine. For more information about the company, please visit http://www.PriCara.com.
Grunenthal, a privately owned pharmaceutical company based in Aachen, Germany, discovered and started development of tapentadol. Grunenthal and J&JPRD have shared development responsibilities for tapentadol for acute and chronic pain conditions since the companies signed a licensing agreement for tapentadol in 2003.
Grunenthal licensed marketing rights to tapentadol to Ortho-McNeil-Janssen Pharmaceuticals, Inc. for the United States, Canada and Japan. Grunenthal maintains marketing rights in Europe and other parts of the world. A trade name for the product has not yet been determined.
[This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Company's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.]
Media inquiries: Greg Panico of Johnson & Johnson Pharmaceutical Research & Development, L.L.C., +1-908-240-2011, +1-908-927-3715
Investor Relations inquiries: Louise Mehrotra +1-732-524-6491, or Lesley Fishman, +1-732-524-3922, both of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
|SOURCE Johnson & Johnson Pharmaceutical Research & Development,L.L.C.|
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